Surgery: light – thermal – and electrical application – Light – thermal – and electrical application – Electrical therapeutic systems
Reexamination Certificate
2000-09-25
2002-04-30
Getzow, Scott M. (Department: 3762)
Surgery: light, thermal, and electrical application
Light, thermal, and electrical application
Electrical therapeutic systems
Reexamination Certificate
active
06381496
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates to an implant device, e.g., a spinal cord stimulation (SCS) system or other programmable implant device. A spinal cord stimulation system treats chronic pain by providing electrical stimulation pulses from an electrode array placed epidurally near a patient's spinal cord. Such a spinal cord system includes several components, ranging from implantable and external components, surgical tools, and software. The present invention emphasizes the manner in which such SCS system, or any other programmable implant system, manages and changes its operational parameters.
The operation of an implanted device depends upon the storage and use of certain operational parameters. For a pulse generator system, e.g., an SCS system, these parameters might include: stimulation pulse amplitudes, pulse durations, channel frequencies, electrode configurations, ramp rates and treatment times, and the like. For a drug delivery system, such operational parameters might further include additional parameters related to the type of drug delivery, the drug medication rate of delivery, all of which may vary over the course of a day. When it is necessary to change the operation of such an implanted device, it is necessary to modify the parameters used by the device as it carries out its intended function, e.g., delivering stimulation pulses, delivering drug medication, sensing physiological activity, or the like. The present invention relates to the manner in which these operational parameters, used by the implant system as it carries out its intended function, are changed and managed. While the invention will be described in the context and background of a spinal cord stimulation system, it is to be understood that the invention has applicability, and can be used with, numerous different types of implant devices and systems, including all types of neural stimulators and sensors, deep brain stimulators, cochlear stimulators, drug delivery systems, muscle tissue stimulators, and the like.
Spinal cord stimulation (SCS) is a well accepted clinical method for reducing pain in certain populations of patients. SCS systems typically include an implanted pulse generator, lead wires, and electrodes connected to the lead wires. The pulse generator generates electrical pulses that are delivered to the dorsal column fibers within the spinal cord through the electrodes which are implanted along the dura of the spinal cord. The attached lead wires exit the spinal cord and are tunneled around the torso of the patient to a sub-cutaneous pocket where the pulse generator is implanted.
Spinal cord and other stimulation systems are known in the art. For example, in U.S. Pat. No. 3,646,940, there is disclosed an implantable electronic stimulator that provides timed sequenced electrical impulses to a plurality of electrodes so that only one electrode has a voltage applied to it at any given time. Thus, the electrical stimuli provided by the apparatus taught in the '940 patent comprise sequential, or non-overlapping, stimuli.
In U.S. Pat. No. 3,724,467, an electrode implant is disclosed for the neuro-stimulation of the spinal cord. A relatively thin and flexible strip of physiologically inert plastic is provided with a plurality of electrodes formed thereon. The electrodes are connected by leads to an RF receiver, which is also implanted, and which is controlled by an external controller. The implanted RF receiver has no power storage means, and must be coupled to the external controller in order for neuro-stimulation to occur.
In U.S. Pat. No. 3,822,708, another type of electrical spinal cord stimulating device is shown. The device has five aligned electrodes which are positioned longitudinally on the spinal cord and transversely to the nerves entering the spinal cord. Current pulses applied to the electrodes are said to block sensed intractable pain, while allowing passage of other sensations. The stimulation pulses applied to the electrodes are approximately 250 microseconds (&mgr;s) in width with a repetition rate of from 5 to 200 pulses per second (pps). A patient-operable switch allows the patient to change which electrodes are activated, i.e., which electrodes receive the current stimulus, so that the area between the activated electrodes on the spinal cord can be adjusted, as required, to better block the pain.
Other representative patents that show spinal cord stimulation systems or electrodes include U.S. Pat. Nos. 4,338,945; 4,379,462; 5,121,754; 5,417,719 and 5,501,703.
The dominant SCS products that are presently commercially available attempt to respond to three basic requirements for such systems: (1) providing multiple stimulation channels to address variable stimulation parameter requirements and multiple sites of electrical stimulation signal delivery; (2) allowing modest to high stimulation currents for those patients who need it; and (3) incorporating an internal power source with sufficient energy storage capacity to provide years of reliable service to the patient. Unfortunately, not all of these features are available in any one device. For example, one well-known device has a limited battery life at only modest current outputs, and has only a single voltage source, and hence only a single stimulation channel, which must be multiplexed in a fixed pattern to up to four electrode contacts. Another well-known device offers higher currents that can be delivered to the patient, but does not have a battery, and thus requires the patient to wear an external power source and controller. Even then, such device still has only one voltage source, and hence only a single stimulation channel, for delivery of the current stimulus to multiple electrodes through a multiplexer. Yet a third known device provides multiple channels of modest current capability, but does not have an internal power source, and thus also forces the patient to wear an external power source and controller.
All such known devices further use different approaches for modifying or changing the operational parameters that control operation of the device. Some allow only the physician or surgeon or other medical professional to make any changes in the operating parameters, thereby making it necessary for the user (the “patient” who receives the benefit from the implant device) to schedule an appointment with such professional if any changes are needed. Often, the changes needed by the patient are relatively benign (insofar as the safety of the altered treatment is concerned), and could easily be made by the patient himself or herself if only the implant device provided such capability. On the other hand, the patient must not be given carte blanche to make wide spread changes in the operating parameters, else he or she could inadvertently set up a treatment regimen delivered by the implant device that could be injurious to the patient's health or damaging to the device. Thus, what is needed is a way for the patient to readily make appropriate changes to the operating parameters of an implant device so long as such operating parameter changes maintain the device operation within safe operating limits. The operating limits should only be changeable by the physician or other medical-professional clinician.
SUMMARY OF THE INVENTION
The present invention addresses the above and other needs by providing an implant device having the ability to perform context switching. As used herein, “context switching” means changing one set of operational parameters to another.
In accordance with one aspect of the invention, an implant device is controlled by a set of operational parameters, and the patient may advantageously swap the current set of operational parameters with another set of operational parameters.
In accordance with another aspect of the invention, the implant device further includes a time-of-day clock, and/or sensor, and automatically changes its operational parameters from one set to another set at certain times of the day, week, or month, or upon the occurrence of certain prescrib
Mann Carla M.
Meadows Paul M.
Advanced Bionics Corporation
Cold Bryant R.
Getzow Scott M.
LandOfFree
Parameter context switching for an implanted device does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Parameter context switching for an implanted device, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Parameter context switching for an implanted device will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-2858825